ABSTRACT
Aim: This study aims to evaluate the effectiveness and safety of teneligliptin when switched from other gliptins in patients notcontrolled on oral antidiabetic drugs in Type 2 diabetes mellitus (T2DM).Methodology: Data of T2DM patients who were switched from other gliptins to teneligliptin uncontrolled by dual or triple drugtherapy. Data of at least 3 months were collected from hospital records and analyzed. Efficacy was evaluated by the changesin fasting blood sugar (FBS), postprandial blood sugar (PPBS), and hemoglobin A1c (HbA1c) from the baseline.Results: A total of 97 patients’ data were collected and were analyzed. The mean age of the patients was 59.9 years andmean duration of diabetes was 16 years. Hypertension (61.9%) was the common comorbid condition with diabetes. Sitagliptinwas most prescribed dipeptidyl peptidase-4 (DPP-4) inhibitors with 65 (67%) patients with a mean dose of 88.5 mg, followedby vildagliptin with 10 (10.3%) patients was prescribed with a mean dose of 95 mg. Metformin and glimepiride were the mostcommon combination used with these DPP-4 inhibitors 91 (93.8%) patients and 69 patients (71.1%) were prescribed, respectively.There was a significant reduction in FBS, PPBS, and HbA1c from the baseline with a difference of 45 mg/dL, 102 mg/dL, and1.6%, respectively, after switching to teneligliptin from other gliptins. Teneligliptin was well tolerated and no serious adverseevents were reported.Conclusion: Teneligliptin was effective in significantly reducing FBS, PPBS, and HbA1c when switching from other gliptins inT2DM patients not controlled with other antidiabetic agents. The drug was well tolerated and no serious adverse events werereported.
ABSTRACT
Background and Aim: According to a strict QT/QTc evaluation study and clinical studies for type 2 diabetes conducted in Japanand other countries, NO AEs related to QT prolongation were detected with 40 mg/day of teneligliptin, which is the maximaldosage used in clinical practice. So far, there are no data regarding the safety of teneligliptin in Indian type 2 diabetic patientswith respect to QTc prolongation. Therefore, the study was conducted to evaluate the safety of teneligliptin in type 2 diabeticpatients with respect to QT prolongation.Methods: A retrospective data were collected from type 2 diabetes mellitus patients with electrocardiogram (ECG) recordswho were treated with teneligliptin along with ongoing treatment. Primary endpoint was to compare the change in the ECGat 3 months from the baseline from the collected data. Mean daily dose (MDD) of antidiabetic drugs, HbA1c, fasting plasmaglucose (FPG), and postprandial plasma glucose (PPG) was also analyzed.Results: A total of 49 patients’ data were collected and analyzed with a mean age of 55.5 years and mean duration ofdiabetes 9.3 years. Hypertension was the most common comorbid disease (63.3%) along with diabetes for a mean durationof 10.0 years. Metformin plus glimepiride were the most prescribed dual drugs (63.3%) along with teneligliptin with an overallMDD of metformin (1065.2 mg) and glimepiride (2.1 mg). From the collected data, there was significant reduction in FPG andPPG at 3 months which were 49.6 mg/dL (P < 0.0001) and 100.5 mg/dL (P < 0.0001) reduction observed from the baseline,respectively. Significant changes were observed in the HbA1c from the baseline to 3 months (0.9%, P < 0.0001). There wasno significant increase in the mean QTc interval from baseline to 3 months. No serious adverse events or hypoglycemiawere reported.Conclusion: Teneligliptin was well tolerated with no significant change in QTc prolongation and significantly effective in reducingthe FPG, PPG, and HbA1c at 3 months from the baseline with no adverse events. There was no increase in the mean QT interval.